Randomized, double blind, placebo controlled study to investigate efficacyof Helicobacter pylori eradication on type 2 diabetes metabolism.

Completed

• Conditions: type 2 diabetes; Helicobacter pylori; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12609000255280
• Lead Sponsor: INRCA Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Type 2 diabetes.
Glycosylated hemoglobin (HbA1c) less than 9.0% at screening.
Body Mass Index (BMI) less than 40 kg/m2.
Able and willing to give written informed consent and to comply
with the requirements of the study.

Exclusion Criteria

Type 1 diabetes.
History of ketoacidosis or lactic acidosis.
Patients treated with insulin.
Patients treated with proton-pump inhibitors.
Use of systemic corticosteroids during the last 3 months.
History of convulsions and/or epilepsy.
Impaired liver function (Alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), total bilirubin or alkaline
phosphatase >2.5 x upper limit of normal (ULN)).
Myocardial infarction < 6 months before screening.
Presence of chronic renal failure.
Serious illness, such as active cancer, major active infection, severe
psychiatric disorders.
Pregnant or lactating women and women with childbearing potential
not using adequate method of contraception.
Partecipation in a clinical trial with an investigational drug within 3
months prior to the screening examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute/relative change in insulin resistance, K index of Insulin Tolerance Test (KITT).[2 timepoints: at baseline and at the end of treatment];Absolute/relative change in insulin resistance, Homeostasis Model Assessment (HOMA) index.[2 timepoints: at baseline and at the end of treatment];Absolute change in Fasting Plasma Glucose (measured by standard laboratory procedures).[2 timepoints: at baseline and at the end of treatment]

Secondary Outcome Measures

Name	Time	Method
Absolute/relative change in insulin-sensitivity related factors<br>(hypertension, Body Mass Index (BMI), waist, Waist/Hip ratio).[2 timepoints: at baseline and at the end of treatment]